Veterinary Medicines

Nobivac KC nasal drops, lyophilisate and solvent for suspension for dogs

Authorised
  • Bordetella bronchiseptica, strain B-C2, Live
  • Canine parainfluenza virus, strain Cornell, Live
Download as PDF

Product identification

Medicine name:
Nobivac KC
Nobivac KC nasal drops, lyophilisate and solvent for suspension for dogs
Active substance:
  • Bordetella bronchiseptica, strain B-C2, Live
  • Canine parainfluenza virus, strain Cornell, Live
Target species:
  • Dog
Route of administration:
  • Nasal use

Product details

Active substance and strength:
  • Bordetella bronchiseptica, strain B-C2, Live
    9.70
    log10 colony forming unit(s)
    /
    0.40
    millilitre(s)
  • Canine parainfluenza virus, strain Cornell, Live
    5.80
    log10 tissue culture infective dose 50
    /
    0.40
    millilitre(s)
Pharmaceutical form:
  • Nasal spray, lyophilisate and solvent for suspension
Withdrawal period by route of administration:
  • Nasal use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI07AF
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Package description:
  • Cardboard or plastic boxes with 50 glass (tiype I) vial closed with a halogenobutyl rubber stopper and aluminium cap, 25 x 1 dose of vaccine and solvent
  • Cardboard or plastic boxes with 10 glass (tiype I) vial closed with a halogenobutyl rubber stopper and aluminium cap, 5 x 1 dose of vaccine and solvent

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • MSD Animal Health Lda.
Marketing authorisation date:
Manufacturing sites for batch release:
  • INTERVET INTERNATIONAL B.V.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 668/00DGV
Date of authorisation status change:
Reference member state:
  • Italy
Procedure number:
  • IT/V/0134/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Ireland
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 13/02/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."